Data / Medical devices / Taiwan / Asus
Asus: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
Asus is registered with the FDA (registration 1000602763) in Taipei City, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 4, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1000602763
- Address
- 1F, No. 15, Li-Te Rd., Beitou Dist., Taipei City, Taiwan, 112
- Owner or operator
- ASUS (10079657)
- Roles
- Specification developer
- First device listed
- December 28, 2023
- Registered through
- 2026
- Brand names listed
- ASUS Ultrasound Imaging System (Model: LU800 series), MH2441A, MH2441A-W, MH2441AY, MH2441AZ, MH2441A-P, MH2441A-J, MH2441A-R, MH2441A-E, MH2741A, MH2741A-W, MH2741AY, MH2741AZ, MH2741A-P, MH2741A-J, MH2741A-R, MH2741A-E,, MH3281A, MH3281A-W, MH3281AY, MH3281AZ, MH3281A-P, MH3281A-J, MH3281A-R, MH3281A-E,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2025 | K250791 | ASUS Ultrasound Imaging System (LU800 series) | IYN | Substantially Equivalent | Asustek Computer, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated December 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.